BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLIFT (VOLUME UNKNOWN)

    MDR report key: 25231798 · Received May 20, 2026

    Report

    Report Number
    3005113652-2026-00496
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 20, 2026
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H.6. TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REPORTER HAS DECLINED TO PROVIDE ABBVIE FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LOWER PART OF THE FACE WITH 1 ML OF JUVÉDERM® VOLIFT® WITH LIDOCAINE, 1 ML OF JUVÉDERM® VOLUX¿, AND 1 ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. FOUR MONTHS LATER, THE PATIENT WAS INJECTED IN THE PREAURICULAR AREA AND MARIONETTE LINES WITH 1 ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND IN THE NASOLABIAL FOLDS WITH 1 ML OF JUVÉDERM® VOLIFT® WITH LIDOCAINE. SEVENTEEN DAYS LATER, THE PATIENT EXPERIENCED ¿EDEMA AND ERYTHEMA¿ IN THE CHIN AREA THAT WAS TREATED WITH A MEDROL DOSEPAK WITH GOOD RESULTS. HOWEVER, 12 DAYS LATER, THE PATIENT EXPERIENCED ¿PAIN¿ WHEN CHEWING. THE PATIENT WAS TREATED WITH AUGMENTIN WITHOUT EFFECT. EVENT WAS ONGOING. THIS FILE CAPTURED THE ADDITIONAL JUVÉDERM® VOLIFT® WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108205 VOLIFT (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention